LCS COMPLETION 2178-56-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295095422), received between Aug 25, 2017 and May 17, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2019Device-Device Incompatibility; Device-Device Incompatibility

  SURGEON COMMENTED THAT THE FEMORAL COMPONENT HOLDER WAS NOT FUNCTIONING PROPERLY. THE SCREW MECHANISM APPEARED TO BE MALFUNCTIONING. THIS DID NOT EFFECT THE PROCEDURE IN ANY WAY IT WAS SIMPLY BEING FLAGGED TO BE REPLACED ONCE THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8621321 ↗
• MalfunctionAug 25, 2017Break; Break

  IT WAS REPORTED THAT THE SURGEON USED THE FEMORAL IMPACTOR AND THE SCREW BROKE ON THE FEMORAL INTRODUCER.

  Patient problems: No Information

  MAUDE report 6820919 ↗